FDA recall D-0815-2021

Product

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16

Reason for recall

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Distribution

Nationwide USA and China

Key facts

Status

Completed

Initiation date

2021-09-03

Report date

2021-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morton Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0815-2021